Remimazolam Tosylate Combined with Low-Dose Propofol Improves Sedation and Safety in Hysteroscopy.
Fan Zhang, Huan Chang, Wenxiang Qing...
https://pubmed.ncbi.nlm.nih.gov/36471692Actively Recruiting
Led by Diansan Su · Updated on 2026-01-13
400
Participants Needed
3
Research Sites
1 weeks
Total Duration
Researchers are evaluating ways to reduce hypoxia, a common adverse reaction during sedation, in patients undergoing transvaginal oocyte retrieval procedures. This trial compares the rate of hypoxia when using a combination of remimazolam and alfentanil versus the commonly used propofol and alfentanil combination to improve patient safety and reduce perioperative complications. The study is a multicenter, prospective, randomized, controlled clinical trial led by Diansan Su. Participants will receive sedation with either the remimazolam-alfentanil combination or the propofol-alfentanil combination. The remimazolam group is given 7 µg/kg of fentanyl first, followed by remimazolam 0.2 mg/kg as a 1-minute bolus, then a continuous infusion at 1 mg/kg per hour. The propofol group receives 7 µg/kg of fentanyl first, then propofol 2 mg/kg as a 1-minute bolus, followed by a 6 mg/kg per hour infusion. Both sedation methods are used during the transvaginal oocyte retrieval procedure. Participants will be monitored throughout their hospital stay, expected to last about two hours, to assess the incidence of hypoxia and related respiratory events. The study will record the occurrence of hypoxia, severe hypoxia, subclinical respiratory depression, and the use of measures to correct hypoxia. Safety and respiratory status will be closely followed during this period to compare the effects of the two sedation combinations.
CONDITIONS
The Efficacy of Remimazolam on Incidence of Hypoxia During Sedated Transvaginal Oocyte Retrieval: A Multicenter Randomized Controlled Trial.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 hours
Participants receive sedation with either remimazolam-alfentanil or propofol-alfentanil during transvaginal oocyte retrieval.
1 sedation and procedure visit (in-person)
Duration - Approximately 2 hours
Participants are monitored for safety and incidence of hypoxia during their hospital stay after sedation and oocyte retrieval.
Continuous monitoring during hospital stay (approximately 2 hours)
Total: 3 locations
1
Dongyang People's Hospital
Dongyang, Zhejiang, China, 322100
Not Yet Recruiting
2
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
3
Lishui People's Hospital
Lishui, Zhejiang, China, 323000
Not Yet Recruiting
D
Diansan Su, Dr.
S
Shuhan Gu, MD.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Fan Zhang, Huan Chang, Wenxiang Qing...
https://pubmed.ncbi.nlm.nih.gov/36471692